Software to control vibration

ABSTRACT

A processor containing software allowing for measuring the speed of a motor, and adjusting that speed by pulse width modulation is provided. A dedicated voltage limiter prevents excess speed, and a battery charge management controller to charge the battery and monitor the battery charge status, ensures battery voltage is regulated to 3.3 V. These additional features contribute to safety, such that when included on an orthodontic remodeling device they allow safe and effective vibration, with minimal changes in frequency and force and no danger of excess speed or power.

PRIOR RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 60/906,807, filed on Mar. 14, 2007, and is a Continuation-in-Part ofU.S. application Ser. No. 11/773,849 (published as US20080227046)(pending) and U.S. application Ser. No. 11/773,858 (published asUS20080227047), both filed Jul. 5, 2007, each of which is incorporatedby reference herein in its entirety. This application is also aContinuation-in-Part of U.S. application Ser. No. 12/615,049 (publishedas US20100055634) (pending), filed Nov. 9, 2009, US application Ser. No.13/609,346 (pending), filed on Sep. 11, 2012, Ser. No. 13/684,220(issued as U.S. Pat. No. 8,500,446), filed on Nov. 22, 2012, and Ser.No. 13/973,865 (pending), filed on Aug. 22, 2013. Each of theseapplications is incorporated by reference herein in its entirety for allpurposes.

FEDERALLY SPONSORED RESEARCH STATEMENT

Not applicable.

REFERENCE TO MICROFICHE APPENDIX

Not applicable.

FIELD OF THE INVENTION

This invention relates to vibrating devices for use in orthodonticremodeling.

BACKGROUND OF THE INVENTION

A malocclusion is a misalignment of teeth or incorrect relation betweenthe teeth of the two dental arches. The term was coined by Edward Angle,the “father of modern orthodontics,” as a derivative of occlusion, whichrefers to the way opposing teeth meet. Angle based his classificationsof malocclusions on the relative position of the maxillary first molar.According to Angle, the mesiobuccal cusp of the upper first molar shouldalign with the buccal groove of the mandibular first molar. The teethshould all fit on a line of occlusion, which is a smooth curve throughthe central fossae and cingulum of the upper canines, and through thebuccal cusp and incisal edges of the mandible. Any variation therefromresults in malocclusion.

There are three classes of malocclusions, Class I, II, and III. Further,class II is subdivided into three subtypes:

Class I: Neutrocclusion Here the molar relationship of the occlusion isnormal or as described for the maxillary first molar, but the otherteeth have problems like spacing, crowding, over or under eruption, etc.

Class II: Distocclusion (retrognathism, overjet) In this situation, theupper molars are placed not in the mesiobuccal groove, but anteriorly toit. Usually the mesiobuccal cusp rests in between the first mandibularmolars and second premolars. There are two subtypes:

Class II Division 1: The molar relationships are like that of Class IIand the anterior teeth are protruded.

Class II Division 2: The molar relationships are class II but thecentral incisors are retroclined and the lateral incisors are seenoverlapping the central incisors.

Class III: Mesiocclusion (prognathism, negative overjet) In this casethe upper molars are placed not in the mesiobuccal groove, butposteriorly to it. The mesiobuccal cusp of the maxillary first molarlies posteriorly to the mesiobuccal groove of the mandibular firstmolar. This malocclusion is usually seen when the lower front teeth aremore prominent than the upper front teeth. In such cases, the patientvery often has either a large mandible or a short maxillary bone.

Orthodontics, formerly orthodontia (from Greek orthos “straight orproper or perfect”; and odous “tooth”), is the first specialty ofdentistry that is concerned with the study and treatment of malocclusion(improper or dysfunctional bite), which may be a result of toothirregularity, disproportionate facial skeleton relationship, or both.Orthodontics treats malocclusion through the displacement of teeth viabony remodeling and control and modification of facial growth.

Bone is remodeled by the concerted activities of 3 celltypes—osteoblasts, osteocytes, and osteoclasts. Osteoblasts are thecells that produce bone extracellular matrix and are responsible for itsmineralization. Osteoblasts also have endocrine activity throughsecretion of osteocalcin, which regulates fat and energy metabolism.These cells also control the differentiation and activity ofosteoclasts. Osteocytes are osteoblasts that have been incorporated intobone matrix and are cells with extensive dendritic processes throughwhich the cells communicate with other osteocytes and with osteoblasts.Mechanical loading is sensitized by the dendritic processes andtransferred to biochemical responses involved in control of osteoblastand osteoclast function. Osteocytes also have endocrine activity byreleasing fibroblast growth factor 23, which is involved in phosphatesecretion in kidneys. Differentiation of osteoclast mononuclearprogenitors to mature multinucleated osteoclasts is regulated bymacrophage colony-stimulating factor and receptor activator of NF-κBligand, expressed by stromal cells in bone marrow or osteoblasts inbone, as well as by osteocytes. The integrated endo- and paracrinecontrol of osteoblasts, osteocytes, and osteoclasts is important formaintaining bone mass and for control of remodeling and modelingprocesses in bone, including during orthodontic-induced tooth movement.

This process of orthodontic bone remodeling has been traditionallyaccomplished by using static mechanical force to induce bone remodeling,thereby enabling teeth to move. This widely accepted approach totreating malocclusion takes about twenty four months on average tocomplete. In this approach, orthodontic braces or appliances, whichconsist of an archwire that applies a continuous static force interfaceswith brackets that are affixed to each tooth. Braces are used to treat anumber of different classifications of clinical malocclusion, includingunderbites, overbites, cross bites, open bites, and crooked teeth, forboth aesthetic and functional/structural reasons.

Orthodontic treatment is complicated by the fact that it isuncomfortable and/or painful for patients, and the orthodonticappliances are perceived as unaesthetic, all of which creates resistanceto use. Further, the 24-month treatment time is very long, and furtherreduces usage and compliance, which can include chronic poor dentalhygiene. In fact, some estimates provide that less than half of thepatients who could benefit from such treatment elect to pursueorthodontics.

Kesling introduced the tooth positioning appliance in 1945 as a methodof refining the final stage of orthodontic finishing after debanding. Apositioner was a one-piece pliable rubber appliance fabricated on theidealized wax set-ups for patients whose basic treatment was complete,but still needed a small amount of refinement. Kesling also predictedthat certain major tooth movements could also be accomplished with aseries of positioners fabricated from sequential tooth movements on theset-up as the treatment progressed. However, this idea did not becomepractical until the advent of 3D scanning and computer modeling in 1997.

Removable clear appliances, such as the Invisalign® system, have beenintroduced for treating malocclusion, and provide greatly improvedaesthetics since the devices are transparent. However, because theseappliances can be removed, compliance can be an issue, and failure touse slows overall treatment time.

As a treatment modality, aligners are also limited in theclassifications of clinical malocclusion that they can address. In thepast, aligners have not been able to easily rotate or extrude teethbecause the aligner cannot adequately direct force in all directions.Conditions that can be difficult to treat with an Invisalign® applianceor are contra-indicated altogether include:

-   -   crowding and spacing over 5 mm    -   skeletal anterior-posterior discrepancies of more than 2 mm (as        measured by discrepancies in cuspid relationships)    -   centric-relation and centric-occlusion discrepancies    -   severely rotated teeth (more than 20 degrees)    -   open bites (anterior and posterior) that need to be closed    -   extrusion of teeth    -   severely tipped teeth (more than 45 degrees)    -   teeth with short clinical crowns    -   arches with multiple missing teeth.

Being aware of these limitations, Align Technologies has recentlycombined the Invisalign® clear aligners with clear attachments thatadhere to teeth and can provide a surface on which force can be exertedin any desired direction. A custom mold is made using a 3D model of thepatients teeth with pockets therein for the placement of a forceattachment, the placement and shape of which are determined usingproprietary modeling software. The relevant force attachments are madeand fitted into the mold, adhesive applied to the attachments, and themold applied to the teeth. This allows precise and quick placement ofthe clear attachments, which are then affixed using light cure. There issome affect on aesthetics, but because the force attachments are alsoclear, they are not very noticeable from a distance.

In addition to static forces, cyclic forces can also be used fororthodontic remodeling. Kopher and Mao assessed cyclic forces of 5 Npeak magnitude at 1 Hz in rabbits, while Peptan and Mao assessed cyclicforces of 1 N at 8 Hz in rabbits, and Vij and Mao assessed cyclic forcesof 300 mN at 4 Hz in rats. In aggregate, the data from these threestudies indicated that cyclic forces between 1 Hz and 8 Hz, with forcesranging from 0.3 N to 5N, increased bone remodeling. Rates depended ondifferent methodologies, but increases of 2.5× with vibrational forceswere common. Since Dr. Mao's experiments, an independent study out ofJapan has confirmed and strengthened the idea of vibration at 60 Hz forspeeding movement, and an earlier 50 Hz study in Russia also confirmsthe basic premise. In fact, by now there is a well establishedliterature confirming the efficacy of this treatment modality.

The early Mao studies provided a basis for both possible efficacy andlikely safety for using vibration in humans to assist orthodontic toothmovement. However, Mao's early experiments were performed on rabbitcranial suture closure model, and no device was ever built that could beused for human teeth. Thus, although suggestive, the work needed to berepeated on human teeth to prove its efficacy. However, no such devicewas available.

OrthoAccel® Technologies Inc., invented the first commerciallysuccessful dental vibrating device, as described in US20080027046,designed to apply cyclic forces to the dentition for acceleratedremodeling purposes. Both intraoral and extraoral embodiments aredescribed in US20080227046, each having processors to capture andtransmit patient usage information. The bite plate was speciallydesigned to contact occlusal as well as lingual and/or facial surfacesof the dentition, and thus was more effective than any prior art devicesin conveying vibrational forces to the teeth.

Further, the device has actually been tested in human clinical trialsand has been shown to speed orthodontic remodeling as much as 50%, andis truly a breakthrough in orthodontic technology (Kau 2010). Finally,the device is slim, capable of hands free operation, lacks the bulkyhead gear of the prior art devices, and has optimized force andfrequency for orthodontic remodeling. Thus, its comfort level andcompliance was also found to be high, with patients reporting that theyliked the device, especially after the motor was redesigned to bequieter and smoother, as described in US20100055634 et seq. In fact,this device has been marketed as AcceleDent® in Australia, the UnitedKingdom, Europe, China, South Korea, Japan, Kenya, and the United Statesand has achieved remarkable commercial success since its recentintroduction (2009). AcceleDent® represents the first successfulclinical approach to accelerate orthodontic tooth movement by modulatingbone biology in a non-invasive and non-pharmacological manner.

However, further improvements in the above device are always beneficial,and this application addresses some of those improvements.

SUMMARY OF THE INVENTION

In one aspect, an orthodontic appliance includes an extraoral vibratorysource and an intraoral dentition interface in the form of a bite plateor platform. A device interface couples the extraoral vibratory sourceto the intraoral attachment.

In another aspect, an orthodontic appliance includes an intraoralvibratory source and an intraoral bite plate or platform that comes intocontact with the dentition.

Furthermore, the bite plate can contact the teeth at any point or at allpoints. The bite plate can contact occlusal surfaces, and preferably,the bite plate contacts lingual or facial (or both) surfaces of theteeth, although specialty plates can be designed for more complexclinical abnormalities.

A processor can control, sample, and compensate the extraoral orintraoral vibratory source. The processor runs software that capturesusage frequency and duration and can be programmed to change the force,frequency, wave form, amplitude, duration or any other operatingparameter. The processor can communicate usage frequency and duration toa remote computer via any type of wired or wireless communicationmethod. The processor can communicate with the remote computer over theInternet, via smartphone, etc.

The processor can actively communicate with the user to provide inputrelated to device use, especially related to biting too hard or not hardenough on the bite plate or platform. A mechanism can be provided tomeasure proper use based on moisture or temperature sensing, or salivarymineral content sensing, or other similar mechanisms, and feedback canbe provided based on this control parameter as well.

Preferably, a custom or semi-custom application-specific integratedcircuit (ASIC) is designed to drive the device, and is particularlypreferred for a completely intraoral device. An ASIC can include entiremicroprocessors, memory blocks including ROM, RAM, EEPROM, Flash andother large building blocks. Such an ASIC is often termed a SoC(system-on-chip). Hardware description language (HDL), such as Verilogor VHDL, can be used to describe the functionality of ASICs.Field-programmable gate arrays (FPGA) are another option for driving thedevice. Programmable logic blocks and programmable interconnects allowthe same FPGA to be used in many different applications. For smallerdesigns and/or lower production volumes, FPGAs may be more costeffective than an ASIC design even in production.

Another option is to use structured ASIC design (also referred to as“platform ASIC design”), because both manufacturing cycle time anddesign cycle time are reduced compared to cell-based ASIC, by virtue ofthere being pre-defined metal layers (thus reducing manufacturing time)and pre-characterization of what is on the silicon (thus reducing designcycle time). Design differentiation and customization is achieved bycreating custom metal layers that create custom connections betweenpredefined lower-layer logic elements. “Structured ASIC” technology isseen as bridging the gap between field-programmable gate arrays and“standard-cell” ASIC designs. Because only a small number of chip layersmust be custom-produced, “structured ASIC” designs have much smallernon-recurring expenditures than “standard-cell” or “full-custom” chips,which require that a full mask set be produced for every design.

Important to usage compliance is that the device is comfortable and notunpleasant to use. The early models had variable speed and force,slowing when the patient exerted more force on the bite plate, and thisirregular vibration caused some irritation and reduced compliance.Therefore, the device was redesigned for smoother (and quieter)operation.

In particular, a constant safe and effective vibration method wasdeveloped, said method comprising providing a vibrating motor with anencoder operably connected to a processor having software that counts atime between a first encoder event and a second encoder event; comparingsaid time to a target frequency; adjusting a motor speed via pulse widthmodulation to increase or decrease said motor speed as appropriate tomaintain said target frequency; such that a vibrating orthodonticremodeling device comprising an intraoral bite plate and an extraoralvibration source employing said method vibrates at a single frequencybetween 20-40 Hz with a variance of ≦2 Hz (e.g, the frequency varies byonly plus or minus 2 Hz from the desired frequency), and a single forcebetween 0.1-0.5 N with a variance of +/−0.05 N (e.g, variation is ≦0.05N) when said bite plate is bitten by a patient and said device isactivated. With the re-designed software and mechanics allowing smoothervibration, compliance increased, allowing further improvement in theaverage speed of remodeling to be observed in the clinical trials.

Another method of maintaining a constant safe and effective orthodonticforce and frequency, comprises providing a processor to control anoffset weight vibration motor and a battery to power said processor andsaid motor; said processor interfacing with an acceleration sensor or anencoder on said motor; measuring a speed of said motor with saidacceleration sensor or said encoder; and regulating said speed of saidmotor by pulse width modulation and by a dedicated voltage regulatorthat limits a drive voltage of said motor; such that an orthodonticremodeling device comprising an intraoral bite plate and an extraoralvibration source employing the method of steps a-d vibrates at a singlefrequency between 20-40 Hz with a variance of only 2 Hz, and a singleforce between 0.1-0.5 N with a variance of +/−0.05 N when said biteplate is bitten by a patient and said device is activated.

Preferably, the method also comprises limiting battery voltage to 3.3 Vusing a battery charge management controller operatively coupled to saidbattery and said processor, and/or limiting the vibration motor's drivevoltage to 1.2 V with a dedicated voltage regulator, and/or whereinadjusting motor speed uses a low-side transistor switch controlled bysaid processor. Also preferred, said encoder is an integrated opticalencoder, and/or the processor is a low power processor, and/or a 32-bitlow power processor.

A non-rechargeable or rechargeable battery can drive the vibratorysource, wherein the rechargeable battery is charged using power from anytype of power source including a USB port, RS-232 port, wall mount DCconverter or a FireWire port, for example. Alternatively, the device canplug into any wall outlet.

Vibration is most commonly provided via a motor that rotates a shafthaving an unbalanced or eccentric weight (off-set motor) or apiezoelectric based device, but any other vibrating means can be used.The known methods of producing vibration include motor and camshaft,motor and linkage, motor rack and pinion, motor and drive belt, andsimilar mechanical methods. However, solenoid vibrators, linear coilvibrators, linear resonance actuators, voice coil actuators, and thelike can also be used. Existing commercial vibration motors include longlife brushless (BLDC) vibration motors, coin (pancake) vibration motors,encapsulated vibration motors, pager motors, PCB mounted vibrationmotors, coreless DC motors, ultrasonic motors, to name but a few.

The ideal vibratory source would be quiet and combinable with a feedbackmechanism to precisely control vibration speed and force. Further, itwould be small, have a good working life at a cost effective price.

A large number of very small vibrating motors are available, as shown inthe table below, but piezoelectric motors may be preferred due to thesmall size, and off-set weighted motors may be preferred due to low costand availability. Particularly preferred are the substantially planarmotors where the vibration is substantially parallel to the substrate(e.g., U.S. Pat. No. 5,554,971, U.S. Pat. No. 5,780,958, US20090224616,US20080129130, US20070103016, WO0178217, each incorporated by referencein its entirety).

Company Catalog Size Specifications ELLIPTEC AG ™ NA 10 × 3 × 2 mm 3-6volts See U.S. Pat. No. 6,870,304 piezoelectric motor SURPLUS MF820 8 ×4 mm 1.5 to 4.5 VDC TRADERS ™ (0.315 × 0.1575 inches) weighted shaftSURPLUS MF918 0.45 × 0.16 inches 1 VDC to 5 VDC TRADERS ™ 18 ohmsWeighted shaft MOTOROLA ™ G13566 0.44 × 0.18 inches 1 VDC to 9 VDC 10ohms Weighted shaft SURPLUS MF835 0.45 × 0.24 inches 1.3 Vdc TRADERS ™100 mA Weighted shaft MATSUSHITA ™ V0296A 0.24 inch diameter 1.5 VDCWeighted shaft SURPLUS ME235 0.24 × 0.5 inches 1.5 to 3 VDC TRADERS ™ 62mA weighted shaft PRECISION 304-002 4 m × 8 mm 2.3 VDC to 3.6 VDCMICRODRIVES ™ 100-120 mA 11000 rpm Weighted shaft PRECISION 308-100 3.4× 8 2.-3.3 V, 120 mA MICRODRIVES ™ 12000 rpm 8 mm Shaftless VibrationMotor

Vibrations may be oscillating, random, directional, circular, and thelike. Vibrators are described in the patent literature (and commerciallyavailable as seen above). For example, US20070299372, US20070255188,US20070208284, US20070179414, US20070161931, US20070161461,US20060287620, each incorporated by reference, describes variousvibrating motors.

Batteries may drive the vibrational source, especially for intraoralembodiments. Small coin batteries, alkaline or lithium, are preferreddue to their small size, but hydrogen batteries may also be preferreddue to their power and power density, particularly as size and costdecrease with further technological development.

For certain embodiments, a battery that can be wirelessly recharged ispreferred for longer product life (e.g., US20090051312, U.S. Pat. No.7,511,454), but in other embodiments a low cost device is manufacturedthat is intended to be single patient use. It is known in the art toselect an appropriate power source/motor combination to provide anorthodontic vibrator that vibrates within the frequency and powersuitable for orthodontic remodeling.

Any off the shelf on/off switch can be used. Particularly preferred forthe intraoral device is an on/off switch with depressible activator(push button, rocker or membrane button).

A leasing, rental or per procedure usage or any other variable usagesystems as well as an out right purchase system enables the extraoralvibratory source or device to be provided to patients at low cost. Thesystem can provide diagnostic information to a service provider. Thesystem also supports recycling the extraoral vibratory source, althoughbite plates are intended to be single patient use components.

In a further aspect, the device delivers non-static forces to changedental tissue including a jaw, mandible or maxilla. The jaw receivessustained non-static forces (e.g, vibration) that are then delivered tothe teeth constituents, and the non-static forces remodel the tissues ofthe mandible, maxilla, or jaw. The device can be used for other type ofmaxillofacial application and trauma like TMJ, Lefort traumaclassification treatment procedures, tooth and other dental implants,among others.

In other aspects, inducing tooth movement and treating malocclusion,craniofacial anomalies, bony defects, and dentofacial deformitiesthrough accelerated bone remodeling are achieved by the deliverynon-static forces; reducing pain and discomfort in patients; andimproving tissue integrity long-term results as to preventpost-orthodontic treatment relapse.

The methods and apparatus include a mechanism for data capture andanalysis related to patient compliance and usage behavior, as well asfor establishing the invention as a component of the clinical officeworkflow to increase efficiency and productivity.

Advantages of the system may include one or more of the following. Thesystem enhances and speeds the traditional orthodontic treatment processwith the application of non-static forces. In accordance with oneembodiment of the system, non-static forces are used to accelerate theremodeling of craniofacial bones in conjunction with orthodontictreatment. The system can be used to treat all forms and classificationsof dental malocclusion, craniofacial anomaly, boney defect, ordentofacial deformity in which bone remodeling plays a physiologicalrole. The system can be used exclusively in the maxilla, exclusively inthe mandible, or in a dual-arch manner (both maxilla and mandible at thesame time). Furthermore, the system can be used to treat casespresenting with a full dentition, any combination of naturally orunnaturally missing teeth, and to remodel bone in edentulous patients.Patients of any age and medical history profile can be treated. Thesystem can be used by patients taking any type of medication.

The system enables orthodontic treatment and tooth movement to beconsidered in the broader context of bone remodeling. The rate-limitingstep for orthodontic tooth movement is osteogenesis. Dynamic loading(cyclic forces) lead to greater osteogenesis or bone growth/boneremodeling, than static forces. Moving teeth is accomplished byremodeling the surrounding alveolar craniofacial bone. Bone remodelinginvolves several steps. First, net bone resorption occurs (osteoclasticactivity) and takes two to three weeks. Second, reversal from netresorption to net formation (osteoblastic activity) takes place.Finally, bone formation fills the cavity in three to four months.Osteoclastic activity typically clears the path for tooth movement fiveto six times faster than osteoblastic activity fills it. Consequently,in order to speed up movement, bone formation (osteogenesis) must speedup.

Certain dynamic loading patterns (higher frequency and inserting restperiods, for example) greatly increase bone formation compared to basicdynamic loading, for example as 1 Hertz sinusoid. Inserting rest periodsis known to be especially efficacious as it allows mechanosensitivity tobe restored to the bone tissue. A point of diminishing returns isreached within each loading session. Therefore, intermittently loadingand uploading with cyclic force can increase the rate of bone formationsignificantly.

The system enables an efficacious, yet quick treatment period thatinvolves rapidly changing the forces on the teeth. This is done withoutrequiring the introduction of piezoelectric currents to the mechanicallystressed bone. Patient compliance is greatly enhanced through computermonitoring of usage. Treatment outcomes are directly dependent on howclosely the patient follows the instructions of the healthcareprofessional. The system can be worn for a predetermined period such asapproximately twenty minutes once a day or more, or any other suitableduration of time, thus the patient can wear the device at home for amodest wear duration.

The healthcare professional, patient, or parent/guardian can measurepatient compliance and usage patterns that have occurred betweenappointments. The measured compliance and application is stored inelectronic means, and is available for retrieval by the health careprofessional; including retrieval over the internet, by smartphone/smartdevice, or any other communication medium. Health care professionals maydirectly down load compliance information to readily available marketpractice software packages.

The system supports a business model that allows for a non-disposablecomponent of the orthodontic treatment to be variable and proportionalin cost to the duration of the treatment. The device can be disposableor non-disposable. The device can be leased, rented, or purchased on aprocedure basis to the patient directly or through the orthodontist orby a third party. The proposed system also increases orthodontic casethroughput and therefore office efficiency.

In more detail, the invention is an orthodontic remodeling devicecomprising an intraoral bite plate having a substantially U-shapedsurface for contacting the occlusal surfaces of teeth, said U-shapedbite plate having an outside edge having upper and lower rims to contactan upper and lower facial surfaces of teeth and gums; said U-shaped biteplate has an inside edge having optional upper and lower rims to contactat least a portion of an upper and lower lingual surfaces of teeth andgums. There is also an extraoral waterproof housing containing arechargeable battery operably coupled to a vibrator (actuator) operablycoupled to a processor for capturing usage data operably coupled to adata-and-charging port for transmitting said data and charging saidbattery. The housing can also have an access hatch therein for accessingsaid data-and-charging port, but not said battery or processor. TheU-shaped bite reversibly and operably connects to said housing, and thedevice is held in place during usage by teeth clamping on the biteplate, and lacks other head attachment means. This feature isparticularly important for compliance, as head-gear is universallydisliked by children and adults.

In another embodiment, the device is an orthodontic remodeling devicecomprising an intraoral bite plate having a substantially U-shapedsurface for contacting an occlusal surface of teeth, said U-shaped biteplate having an outside edge having upper and lower rims to contact anupper and lower facial surfaces of teeth and gums; said U-shaped biteplate having an inside edge having upper and lower rims to contact atleast a portion of an upper and lower lingual surfaces of teeth andgums; an extraoral waterproof housing containing a rechargeable batteryoperably coupled to a vibrator (or actuator) operably coupled to aprocessor operably coupled to a USB port; said housing also having anaccess hatch therein for accessing said USB port, but not the processoror battery, said access hatch tethered to said housing; said batteryand/or access hatch accessible only with a tool; said U-shaped biteplate reversibly and operably connected to said housing; saidorthodontic remodeling device having a noise level less than 55 dB whenmeasured at 6 inches, and being capable of vibrating at a frequency of20-40 Hz, with a variance of only 2 Hz, and a force of 0.1-0.5 Newtons,with a variance of +−0.05 N, or similar; wherein said device is held inplace during usage by teeth clamping on the bite plate, and lacks otherhead attachment means.

In yet another embodiment, the device consists essentially of: anintraoral bite plate having a substantially U-shaped surface forcontacting an occlusal surface of teeth, said U-shaped bite plate havingan outside edge having upper and lower rims to contact an upper andlower facial surfaces of teeth and gums; said U-shaped bite plate havingan inside edge having optional upper and lower rims to contact at leasta portion of an upper and lower lingual surfaces of teeth and gums; anextraoral waterproof housing containing a charging port operably coupledto a rechargeable battery operably coupled to a vibrator (or actuator)operably coupled to a processor operably coupled to a data port; said Ushape bite plate reversibly and operably connected to said housing; saidorthodontic remodeling device having a noise level less than 55 dB whenmeasured at 6 inches, and being capable of vibrating at a frequency of20-40 Hz, with a variance of only 2 Hz, and a force of 0.1-0.5 Newtons,with a variance of +−0.05 N, or similar.

In another embodiment, the orthodontic device consists essentially of anextraoral vibratory source (or actuator); an extraoral processor thatcontrols said extraoral vibratory source; a power source that drivessaid vibratory source; an intraoral attachment consisting of a biteplate allowing for contact with an occlusal surface and at least one oflingual and buccal surfaces of a patient's teeth, wherein a patientbiting on said bite plate holds said device in place during use; whereinthe extraoral vibratory source is coupled to the intraoral attachment;wherein said orthodontic device is hermetically sealed and can vibrateat a frequency of 0.1-400 Hz.

In another embodiment, the orthodontic device consisting essentially ofan extraoral vibratory source (or actuator); an extraoral processor thatcontrols said extraoral vibratory source and captures and transmitsusage frequency and duration; a battery that drives said extraoralvibratory source; an intraoral attachment consisting of a bite plateallowing for contact with an occlusal surface and at least one oflingual and buccal surfaces of a patient's teeth, wherein a patientbiting on said bite plate holds said device in place during use, whereinthe intraoral attachment is coupled to the extraoral vibratory source;wherein said orthodontic device is hermetically sealed; wherein thatwhen activated, said orthodontic device can vibrate at a frequency of0.1-400 Hz.

In yet other embodiments, the device is completely intraoral, and thebite plate as described herein also has the power source, vibratorysource, and processor directly thereon, although the processor can beomitted in a low cost device. The device should be hermetically sealedor otherwise waterproof, and thus wirelessly recharging batteries wouldbe preferred, or long lasting batteries can be coupled with a low costdevice. Since there is limited room inside the mouth a coin vibrator orother microvibrator may be the best vibratory source, coupled with e.g.,a membrane button off/on switch, preferably accessible by the molars.Placement of these electronic components on the bite plate can either bebuccal or lingual or occlusal, depending on the size of the components,but preferably is not labial (under the lips), as that interferes withuse and aesthetics.

Methods of orthodontic remodeling, are also provided, comprising bitingthe bite plates, as described above, and activating the vibrator forabout 5, 10, 15 or 20 minutes or more. This can be daily, or preferablytwice daily, or more. Since the device speeds orthodontic remodeling,overall orthodontic treatment time is reduced, e.g., from an average oftwo years to one.

The use of the word “a” or “an” when used in conjunction with the term“comprising” in the claims or the specification means one or more thanone, unless the context dictates otherwise.

The term “about” means the stated value plus or minus the margin oferror of measurement or plus or minus 10% if no method of measurement isindicated.

The use of the term “or” in the claims is used to mean “and/or” unlessexplicitly indicated to refer to alternatives only or if thealternatives are mutually exclusive.

The terms “comprise”, “have”, “include” and “contain” (and theirvariants) are open-ended linking verbs and allow the addition of otherelements when used in a claim.

The phrase “consisting of” is closed, and excludes all additionalelements.

The phrase “consisting essentially of” excludes additional materialelements, but allows the inclusions of non-material elements that do notsubstantially change the nature of the invention. Thus, the termconsisting essentially of excludes such elements as bulky head gear,designed to hold the device in place during use, tooth brush bristles,lasers, and the like, which would fundamentally change the nature anduse of the device. The phrase would not, however, exclude elements suchas additional LED lights, speed dials or other control buttons, batterycharge indicators, accessories, variations in bite plate shape,variations in wiring, or variations in software, processor orcommunication technology, and the like.

As used herein, all nomenclature is per standard dental usage. Thusbuccal surfaces, refers to cheek facing surfaces, labial to lip facing,lingual to tongue facing, and facial includes both labial and buccalfacing surfaces.

By “U-shaped” what is meant herein is that the bite plates follow thecurvature of the dentition, e.g., the biting surfaces of the teeth arein a substantially U-shaped curvature.

By “lingually shaped,” what is meant is that a device is tongue shaped(e.g., like a U that has been filled in) such that it could function,e.g., as a palatal expander or retainer.

When we refer to contacting “the teeth” or similar phrase herein, whatis meant is the entire dentition, e.g., the teeth of both arches. Ifless than the entire dentition is intended, it will be referred to asmaxillary teeth, mandibular teeth, or a “portion” of the teeth orspecific teeth or arches will be identified by name. Nevertheless, thebite plate need not contact every single tooth, since by definition somemalocclusions may results in one or more teeth considerably out ofalignment. The phrase also allows some leeway at the molars toaccommodate the fact that dentition varies in size, and that molarserupt over 20-25 years of age, if at all, or may be removed to provideadditional space for the remaining teeth, and thus most patients willnot have a full set of adult teeth. Therefore, a bite plate intended tocontact all teeth of the average youth patient, may not reach the molarsof older or larger patients, or patients with more mature dentition.

By “treatment modality” what is meant is a mode of action that causes anorthodontic benefit.

By “treatment modality source,” what is meant is a device or componentof a device that provides the treatment modality. For example, vibrationis an orthodontic treatment modality and a vibratory source providesvibration. A vibratory source could also be called a vibrator. Anothertreatment modality is infrared or ultraviolet light, and an LED or lasercould be an exemplary light source.

A “bite plate” as used herein means a device worn inside the mouth andgenerally contacting occlusal surfaces of the teeth, such that thedevice is held by the patient “biting” on the bite plate.

An “extraoral driver” is the extraoral component that provides thetreatment modality, and in preferred embodiments is a housing having ane.g., a treatment modality source such as a vibrator or laser, aprocessor, a battery or other power source, and the wiring needed tooperatively couple or operate same, and wherein the housing has a socketfor receiving the connector of the intra-oral bite plate. The housingwill preferably be water resistant or waterproof.

By “socket” what is meant is a hole or recession or female end intowhich a male end connector can fit.

By “housing” is used for the exterior surface or container for theextraoral driver components.

“Orthodontic remodeling” is used consistently with its art-accepteddefinition, and refers to the realigning of teeth by boney remodelingunder forces sufficient to provide osteoclastic activity on thehigh-pressure side, and osteoblastic activity on the reduced-pressureside, but with minimal root resorption, such that teeth are graduallymoved and/or realigned to a desired position.

“Orthodontic forces” is used consistently with its art-accepteddefinition, and refers to the steady (static) realigning forces neededfor orthodontic remodeling. Cf Micropulses.

“Micropulses” are the very small vibrations or cyclic forces that arenow known to cause 50% faster orthodontic remodeling when combined withan orthodontic force.

“Orthodontic remodeling appliances” or “orthodontic appliances” are usedconsistently with art-accepted definitions, and refers to those devicesthat provide orthodontic forces and thus the realigning of teeth. Theterm includes a variety of devices, such a braces, aligners,positioners, Herbst, sagittal appliance, palatal expander, pendulum,Nance, and the like. The term does not include tooth cleaning devices,such as electric toothbrushes, or professional cleaning tools such asscalers, and the like.

“Headgear” is used consistently with its art accepted definition, andrefers to various head and neck attachment means used to provideorthodontic forces in a particular direction that cannot be easily beachieved with intra-oral attachment points. As one example, headgearmight be used to pull the mandible forward to help correct class IImalocclusions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A-B shows one embodiment of an orthodontic treatment system,wherein the electrical components are all extraoral and contained withina housing.

FIG. 2A-B shows a second embodiment of an orthodontic treatment systemwherein all component are intraoral.

FIG. 3 shows an exemplary diagram of control electronics used with thesystem of FIGS. 1-2.

FIG. 4 shows an exemplary dental treatment network.

FIG. 5 shows an exemplary process for treating patients.

FIG. 6 shows an exemplary process to capture data and provide data forfeedback purposes.

FIG. 7 shows an exemplary system for leasing, renting or purchasing theappliances.

FIG. 8 shows an exemplary process for improving office and caseefficiency.

FIG. 9 is an exemplary process to compare differences in pain level andimproved treatment time for patients treated with and without theappliances.

FIGS. 10 A and B shows a perspective view of a bite plate from twoangles, showing the flat U-shaped base, and upper and lower lingual andfacials rims, as well as the stem, which fits into a mating socket onthe extraoral housing (not shown).

FIGS. 11 A and B shows the core of the bite plate from two angles, overwhich is molded a biocompatible overlay having the rims and desiredfinal shape.

FIG. 12 shows a top view of the bite plate, more clearly illustratingthe stem, flare, pins, cylindrical shaft and groove, into which fits thejump ring that mates with a corresponding recess in the socket (notshown).

FIGS. 13 A and B shows a USB embodiment from two angles, wherein the USBis housed inside an access hatch that is tethered to the main body ofthe housing, and the USB functions for both recharging and datatransmission purposes.

FIG. 14A-B shows exemplary usage data graphics. FIG. 14A shows theoverall graphic design, providing daily %, 30 day %, minutes of use andnumber of sessions on a single graph. The small horizontal bar with greyusage data on the bottom has movable cursors or scroll icons (see smallboxes at each end) and allows the user to select the date range forviewing. Thus, the patient, parent/guardian, or healthcare professionalcan look at an entire multi-month or multi-year history, or can focus onthe most recent month's usage. FIG. 14 B shows how that data for asingle day (see dots) can be selected for display by passing the cursor(arrow) over the data. The selected day's data is then displayed in thesummary at the top right.

FIGS. 15A-C show an exemplary circuit diagram.

FIG. 16 shows a graph of force in Newtons on the Y axis, versusfrequency in Hz on the X axis, and plotted are patient reactions to thevarious combinations of force and frequency. Generally, the higher thefrequency, the less force should be used in order to provide a devicethat will have good patent acceptance.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with one embodiment of the invention, non-static forces(e.g., vibration) are used to accelerate the remodeling of craniofacialbones in conjunction with orthodontic treatment. The system can be usedto treat all forms and classifications of dental malocclusion,craniofacial anomaly, boney defect, or dentofacial deformity in whichbone remodeling plays a physiological role. The system can be usedexclusively in the maxilla, exclusively in the mandible, or in adual-arch manner (both maxilla and mandible at the same time).Furthermore, the system can be used to treat cases presenting with afull dentition, any combination of naturally or unnaturally missingteeth, and to remodel bone in edentulous patients. Patients of any ageand medical history profile can be treated. The system can be used bypatients taking any type of medication.

FIG. 1A-B shows one embodiment of an orthodontic device 10. The device10 has an intraoral bite plate 20 that is inserted into a patient'smouth. The bite plate 20 is connected to an extraoral vibration source30. The device 10 is held by the patient's jaw 40 clamping on the biteplate 20 to secure it between the dental arches 42. No other attachmentmeans are needed, and thus this greatly simplifies the device andpatient comfort, which serves to greatly improve compliance.

The bite plate 20 can interface with any part of the dentition 32, notbeing confined to a particular arch, region, quadrant, or tooth, and notbeing confined to either natural dentition or prosthetic dentition,although we have illustrated a generally useful shape herein, thatcontacts all teeth. By “all teeth” herein, we mean that the bite platecontacts from the most distal tooth through the most mesial tooth ofboth upper and lower arches. However, one or more teeth may not actuallytouch the bite plate due to malocclusion. If malocclusion is severe, thebite plate can be adapted through peel and stick risers to contactmisaligned teeth or a custom bite plate can be built.

The extraoral vibration source 30 in this embodiment is activated bypushing a button 38 mounted on the extraoral apparatus. The vibratorcould alternatively be activated by sensing the patient bite pressure asstimuli with a microprocessor 39 or some other mechanism translating theexternal stimuli into device function, including moisture or temperaturesensing as well as salivary mineral content sensing.

The extraoral vibration source 30 in more detail includes a vibrator oractuator 54, which can be an off-set motor, piezoelectric vibrator, orany other means for producing vibration. The actuator 54 is operablycoupled to the processor 39, which is operably coupled to battery 62.The extraoral vibration source 30 is also connected to the bite plate insuch as way as to transfer the forces produced by actuator 54 to thebite plate 20 and thus the teeth and bone of the user. The entireextraoral vibration source 30 is preferably enclosed in a housing (notdetailed in this figure), which is preferably watertight or at leastwater resistant. Furthermore, the wiring, software, connections,couplers and the like needed to make a functional vibratory source arenot detailed in this figure, but various ways to implement same areknown in the art.

In another embodiment shown in FIG. 2A-B, the vibration source 30 ispositioned intraorally and the bite plate holds the components necessaryto generate and apply the force. This embodiment can generate and applynon-static forces to either the maxillary or mandibular arch or both.This particular embodiment involves a dual arch configuration that workswith both dental arches 40. The patient inserts the bite plate 20 intothe oral cavity and bites down, holding the device 10 steady between theteeth, regardless of which of the arches 40 the device is beingactivated for use. The vibration source 30 contained in the intraoralcompartment 36 is activated by pushing a button 38, which activatesactuator 54, causing the entire bite plate to vibrate. The vibrationsource 30 could alternatively be activated by sensing the patient bitepressure as stimuli with a microprocessor 39 or some other mechanismtranslating the external stimuli into device function.

An intraoral compartment on the midline and facial side of the device isshown, but it could also be contained on the lingual side, or two ormore vibrators can be provided, e.g., on the molars. The entirety of themechanism is hermetically sealed to render it waterproof.

In one embodiment, the device works when the patient applies sufficientforce by biting on the device or otherwise clamping the jaws on thedevice. This enables the device to control the provision of cyclicforces when the correct amount of force is applied. In this embodiment,the device includes 1) microprocessor and compliance software andreporting system; 2) ability to provide cyclic forces at any level; and3) the ability to only provide the cyclic force when the teeth apply thecorrect force on the device. An activation trigger can also be tied tosome other stimuli including temperature or moisture sensing as well assalivary mineral content sensing.

FIG. 3 shows a diagram of exemplary control electronics used with thedevice. The functional electromechanical components include a processor39 that can be a low power microcontroller. The processor 39 storesinstructions and data in its memory 52. The processor drives theactuator 54, such as an electrical motor or a piezoelectric device,among others. The system of FIG. 3 receives energy from a battery 62that can be rechargeable. The processor 39 can be programmed or updatedor transmit data through a communication port 60 such as a USB port orwireless transceiver 58 connected to an antenna 59. The battery 62 canbe of any type and can be a rechargeable type with a docking port thatrecharges the battery upon insertion thereto. The processor 39 can alsocommunicate with an optional sensor 64 to capture patient dental data ifneeded. The processor 39 can also simply transmit its operationalparameters through the communication port 60 or the wireless transceiver58 so that a dental professional such as a dentist, an orthodontist, aclinical trial monitor, a hygienist, a treatment coordinator, a staffmember, a patient, or a third party can monitor treatment progress asrequired.

The actuator 54 can be directly attached to the bite plate or platform,as shown in the intraoral embodiment of FIG. 2, or be extraoral as shownin FIG. 1. Upon activation, the bite plate or platform, which can be ofany shape or thickness, and comprised of any material, vibrates in amanner that delivers the necessary force. In preferred embodiments, thebite plate contains a solid core that is stiff enough to transmitvibration to the teeth, e.g., 30-40 Shore D, and is covered by abiocompatible coating or housing that is softer, e.g., 60-80 Shore A.

Preferably, the coating will not have an objectionable taste and will bebiocompatible, safe, and Food and Drug Administration-approved, such assilicone rubber, polypropylene, HDPE, and the like. In anotherembodiment the bite plate coating and other parts of the appliance thatcontact oral tissues have a selection of flavorings for additionalcomfort in use of the appliance. In yet another embodiment, the deviceis coated with a polymer that can be reshaped for custom fit, such asboil and bite polymers, or polymers that can be activated, cured and/orset with the addition of light and/or chemicals.

The device can have one or more interface points across the dentition,or can interface with the entire dentition in aggregate and in botharches simultaneously. The system embodied as the device described herepulsates or vibrates at a frequency of between about 0.1 Hertz to about1200 Hertz, but 1-400 Hz is preferred, and especially 5-20 Hz.

Ultrasonic frequencies might also be used, as there is some data showingthe usefulness of ultrasound to speed bone remodeling. However,successful use in a dental application has not yet been shown. Further,it is possible that use of ultrasound may be very irritating in suchproximity to the patient's head, thus rendering such a device of novalue even if ultrasound has biological effects. A device cannot haveany efficacy if the patients won't use it.

In one embodiment, the interface with the dentition 32 can transmit aforce of about five Newtons (5N) for about twenty minutes a day at afrequency of between 0.1 to 400 Hz as discussed above. However, forcesof less than 1 Newton, especially 0.1-0.5 or 0.2-0.3 N are morepreferred by patients and have been shown to be clinically effective andwithout causing root resorption, which occurs if too much force isapplied. Excess force is generally unpleasant to the patient, especiallyhigh force coupled with high frequency, and in preferred embodimentsthese parameters are adjustable within clinically acceptable limits.

The prescribed clinical application of forces can be over any duration,frequency, and time of day combination pattern. Upon completion of atwenty-minute duration of activation, the device can automatically shutoff. Pacing indicators in the form of an audible tone, visual lights,cycle stutter, or by some other means provide feedback to the patientregarding elapsed time and time remaining in the current session ofactivation are also beneficial. These indicators can be of any form andfrequency. A prototype system embodies the indicators as one secondtones at five-minute intervals for the first fifteen minutes,representing a tone at minute five, minute ten, and minute fifteen; andthen a final tone at minute nineteen, indicating that the user has 60seconds of use remaining Other indicators and/or suitable treatmentintervals can be used to provide notice to the patient. For example, theprofessional can specify treatment intervals that mixes and matches theusage pattern to get to the 20 minutes such as 4×5 minutes or 10×2minutes or some other combinations thereof.

After the device shuts off, the patient simply releases bite pressurefrom the intraoral bite plate and removes the device. Data capturerelated to usage frequency and duration updates in real time. As such,the device representation of this data post-use will indicate oneadditional session, and twenty additional minutes in duration of use, ascompared to the same device immediately prior to the session.

In one embodiment, the battery 62 is rechargeable and can be insertedinto its charger base between uses. Alternatively, the device can embedthe battery 62 within its housing, and the entire device is placed intoa rechargeable base (or the battery does not require recharging). Thecharging of the battery can also be done using power received from theUSB port 60, and this is particularly preferred. Thus, the charging portand the data port can be the same port. Alternatively, any suitablecomputer or electrical connection can be provided to charge the battery.For example, the battery can be charged using RS-232, Firewire, orthrough a 5V hook. Further, a standard wall mount DC converter can beused to charge the battery.

If a USB port is provided it should be protected inside the housing, andaccessed via an access hatch or removable cap that is preferablytethered or somehow attached to the main body of the housing. While notessential for operability, it is preferred that the access hatch andbattery be only accessible with a tool because this makes the devicesafer and eases the regulatory burdens. Alternatively, it may bepossible to provide a waterproof USB port, but this will increase costs.Preferably, the battery and processor are not patient accessible either.

The device is hermetically sealed to be airtight and water tight, or atleast water resistant, and can withstand exposure to water or moisture.It can and should be stored at room temperature. The battery 62 used inthis particular embodiment is both memory-free and maintenance-free. Thedevice can have a charger base, or can be inserted just long enough tocharge for the next use.

The application of cyclic forces can be used to perform bone modelingand/or remodeling as well as more rapid tooth movement that may occurwithout bone modeling or remodeling. The bone remodeling and acceleratedtooth movement across all types of displacement includes: rotation,translation, intrusion, extrusion, and tipping. This induced acceleratedremodeling of bone is relevant for both the alignment and movement ofteeth, in any plane, including horizontal and vertical, anterior andposterior, mesial and distal, and facial (e.g., buccal and labial) andlingual.

The delivery of the cyclic forces to the teeth and craniofacial bonescan be facilitated by contact or any form of interaction with thedentition, including any tooth, group of teeth, or arch or by contactwith braces or aligner or positioner. The interface can also include anydental tissue including tissues of the tooth, enamel, dentin, cementum,and pulp, and appliances, especially aligner trays, which can be of anycommercial or non-commercial brand or design.

The device can be used to move either a single tooth, the entiredentition, or any combination of teeth groups. Teeth being displaced asa result of the non-static forces delivered by this device can includenatural teeth without any dental work, natural teeth with dental workincluding operative restoration of any nature with any material, crownand bridge work, endodontically treated teeth, periodontally treatedteeth, teeth surrounded by periodontally treated hard and soft tissue,and any type of dental implant, including micro implants used fororthodontic or tooth movement purposes. The proposed system can be usedin conjunction with any type of dental or dentofacial surgery ortreatment of trauma to any soft or hard tissue structure.

The system can be used in conjunction with lingual braces, facialbraces, or any combination across either arch or any quadrant for both.It is also being contemplated as compatible with any robotics-based orother wire-bending optimization technology. The system is alsocompatible with clear aligner technology treatment plans, including theInvisalign® treatment approach, both with and without force attachments.

The system can be used in conjunction with a new treatment start fromthe very first appointment at which the orthodontic treatment begins, orit can be slotted into a treatment in progress at any point during thecourse of the treatment, up to and including the very last clinicalstage.

In another aspect, the vibrating dental device can be used inconjunction with any currently used or in-development chemical,biochemical, and tissue engineering treatment approaches to acceleratingtooth movement or remodeling craniofacial bone. These treatments mayinclude growth factors, cytokines, matrix metalloproteinases (MMPs),tissue inhibitors of metalloproteinases (TIMPs), and regulation ofextracellular matrix molecules. In addition, for both repositioning orstabilizing, tissue remodeling and/or an angiogenic substance(s) can beadministered to the patient to promote remodeling of periodontal tissuesurrounding the root(s) of the tooth or teeth to be moved. Preferredsubstance(s) will bind to and activate the relaxin receptor in thetissues which anchor the teeth or other craniofacial structures. Mostpreferred is relaxin or an analog or mimetic thereof which combinestissue remodeling activity with angiogenic activity. Analogs includepeptides, oligomers, fragments, etc. which comprise the active region ofnative relaxin and mimetics include small molecule drugs, typicallybelow 2 kD, designed to mimic the activity of native relaxin.Alternatively, substance(s) with predominantly angiogenic activity couldbe selected, such as VEGF, bFGF, estrogen, nitrous oxide, naltrexone, orthe like. Further alternatively, collagenases or other tissue-softeningenzymes could be utilized to promote periodontal tissue remodelingaccording to the present invention.

FIG. 4 shows an exemplary dental treatment network. The device 10transmits operational and dental/medical information while embedded in apatient 1. The data is received by a local processor 99. The localprocessor 99 in turn uploads the information over a wide area network102 such as the Internet. The data can be received by a treatingprofessional such as a dentist or an orthodontist at workstation 120.The information can also be sent to one or more diagnostic specialists130 who review the information and then make recommendation to thetreating professional over the network 102. The information can also besent to the device's manufacturer 110 and any other required dentalsupplier 140.

An Internet community with one or more dental supply companies, serviceproviders, manufacturers, or marketers is connected to the network 102and can communicate directly with users of the client workstations 99 orindirectly through the server 100. The Internet community provides theclient workstations 99 with access to a network of orthodonticspecialists and dental specialists. Additionally, the Internet communityalso provides access to a variety of supporting members such asfinancing firms, leasing firms and other service providers, amongothers.

In another embodiment, the device can send data to a smart phone, whichcan thus remind the user to use the device, or can send the data tothird party for use in a clinical trial, or by dental practitioners orparents.

Although the server 100 can be an individual server, the server 100 canalso be a cluster of redundant servers. Such a cluster can provideautomatic data failover, protecting against both hardware and softwarefaults. In this environment, a plurality of servers provides resourcesindependent of each other until one of the servers fails. Each servercan continuously monitor other servers. When one of the servers isunable to respond, the failover process begins. The surviving serveracquires the shared drives and volumes of the failed server and mountsthe volumes contained on the shared drives. Applications that use theshared drives can also be started on the surviving server after thefailover. As soon as the failed server is booted up and thecommunication between servers indicates that the server is ready to ownits shared drives, the servers automatically start the recovery process.Additionally, a server farm can be used. Network requests and serverload conditions can be tracked in real time by the server farmcontroller, and the request can be distributed across the farm ofservers to optimize responsiveness and system capacity. When necessary,the farm can automatically and transparently place additional servercapacity in service as traffic load increases.

The server 100 can also be protected by a firewall. When the firewallreceives a network packet from the network 102, it determines whetherthe transmission is authorized. If so, the firewall examines the headerwithin the packet to determine what encryption algorithm was used toencrypt the packet. Using this algorithm and a secret key, the firewalldecrypts the data and addresses of the source and destination firewallsand sends the data to the server 100. If both the source and destinationare firewall protected, the only addresses visible (i.e., unencrypted)on the network are those of the firewall. The addresses of computers onthe internal networks, and, hence, the internal network topology, arehidden. This is called “virtual private networking” (VPN).

The system improves patient compliance, defined as duration of deviceuse/wear, frequency of device use/wear, consistency in time of daydevice use/wear, and correct device use/wear such data is captured indata form by the device. Compliance refers to both not overusing and notunderusing the device in accordance with the instructions given to thepatient by the healthcare professional. This data can be viewed by thehealthcare professional, as shown in FIG. 5. In this embodiment,instructions for use and wear are provided to the patient by thehealthcare professional (510). The patient uses/wears the device, anddata on compliance is captured during patient use (512). After eachtreatment period, the device is retrieved by the professional andcompliance data is extracted therefrom (514). The data is presented in aform that will allow for data analysis by the healthcare professional(516). As a part of an active feedback process (518), the healthcareprofessional then makes recommendations, or re-prescribes, the devicefor subsequent use until the next visit or interaction. This process caninvolve some form of reward or punishment based on the compliance andusage pattern results. Alternatively, the device can be configured toautomatically communicate usage to a central location, e.g., viasmartphone and thus near real-time monitoring will be possible.

As shown in FIG. 6, the data can be provided either directly to thepatient or to the legal guardian for feedback purposes as well. Thedevice can be configured as seen in FIG. 6 to provide either active orpassive feedback to the patient user. This data generation andobservation can be enabled by a request via download with some form ofelectronic media, or delivered as a default setting during use. Forexample, during use, the device can provide visual feedback upon request(612) from the patient or automatically (614). The data can bedownloaded (616) into an electronic media 620 such as a flash drive andthe information can be sent to the professional for feedback andanalysis (618), or to the patient directly or to the legal guardian ofthe patient (619).

FIG. 7 demonstrates an exemplary distribution system by company 700where the device 10 is leased or rented to the patient 730 through theorthodontic office 720, allowing for the patient fee to be proportionalto the amount of time that the device is used as a part of thetreatment. Alternatively, the patient could rent or lease the devicedirectly from the commercial sales organization or manufacturer asdemonstrated in FIG. 7. The patient could also purchase the applianceinstead of leasing or renting the device 10, either from the orthodonticor healthcare professional office 720 or from the commercial salesorganization or manufacturer 700.

An additional aspect of the proposed system is related to the efficiencyimprovement that it allows and enables within the orthodontic or otherhealthcare professional office. It can be used to decrease treatmentduration times, increase the number of new starts, improve financialperformance of the practice across any metric, attract new patients,recruit former treatment-rejecters, and improve relations with upstreamor downstream referring or referral dental/medical professionals of anydiscipline or specialty.

Healthcare professional efficiency increases as a result of patientsusing the system. This improvement could include metrics such as anincreased number of new case starts, a shorter duration of totaltreatment time, frequency of recall or adjustment visits, or a decreasedamount of chair time, as shown in FIG. 8. In FIG. 8, the orthodonticoffice exists in a steady state in office and case efficiency withoutthe device (810). As the adoption of the technology is increased and thedevices are incorporated into patient cases, an improvement in theoffice and case efficiency is achieved (820). These efficiencyimprovements can occur as a part of or as a result of any stage oforthodontic treatment of any malocclusion classification, and with anyarchwire or appliance type, including all wire sizes, shapes, andcompositions.

FIG. 9 shows an exemplary process to compare differences in pain leveland integrity of clinical outcomes, respectively, for patients treatedwith and without the devices invented herein. FIG. 9 demonstrates adecrease in patient pain and discomfort as a result of using the device,and also that treatment time is substantially reduced (by as much as50%, depending on compliance). In FIG. 9 the healthcare professionaltreats the patient without the device of the present invention (910) andthe level of pain and/or discomfort is observed by the treatingprofessional or reported by the patient. The healthcare professionalthen treats the patient with the device of the present invention and thelevel of pain and/or discomfort is observed by the treating professionalor reported by the patient is captured (920). The difference between thepain level in patients treated with or without the device can beanalyzed. The device treats patient with less pain, and the treatmentresult could be in the form of improved tissue integrity. Similarly,improved treatment times, by as much as 50% are shown, and this level ofbenefit has been clinically validated.

FIG. 10A-B shows an improved bite plate (1000), having generallyU-shaped base (1001) that contacts occlusal surfaces of the teeth, thebase having front and back edges, one or both edges having a rim tocontact the facial and lingual surfaces of teeth and/or gums. Thus,upper lingual rim (1002), lower lingual rim (1003), upper facial rim(1005) and lower facial rim (1006) are shown. In this instance, thelingual rims contact only the incisors and/or canines, but not themolars. However, the rims can be varied in length to contact all, or aportion, of the teeth. It is preferred that at least one rim contacteach tooth, except for specially designed bite plates made to correctextreme abnormalities.

Also shown in FIG. 10A-B is the stem (1008), which is the portion of thebite plate (1000) that mates with a corresponding socket in theextraoral housing (not shown here). In more detail, a cylindrical shaft(1009) is shown, having a groove (see FIG. 11) into which a jump ring(1010) fits, and mates with a corresponding depression in the socket.Optional flare (1112) is also shown, and is configured to provide anappropriate surface so that the user can push the stem into the socket.Because of this snap-fit feature between the bite plate and theextraoral housing, the bite plate can therefore reversibly connect tothe extraoral housing, which enables easier cleaning and/or storage.

The thickness of the biocompatible overlay material can be adjusted tocompensate for various patient bite configurations (open, deep, flat),as detailed in US20100055634, incorporated by reference herein. However,in most instances a bite plate that is slightly thinner at the distalend than the mesial end will accommodate the hinged nature of thetemperomandibular joint and facial skeleton.

Thus, if a U-shaped bite plate has two back ends that can contact one ormore distal or posterior teeth, and a front end that can contact one ormore mesial or anterior teeth, and a thickness E, wherein said thicknessE is 2-10 mm, the bite plate can be in one of three configurations:

a) thickness E does not substantially vary from said front end to saidback ends;

b) thickness E increases from E at said front end to E plus 0.5-10 mm atsaid back ends;

c) thickness E increases from E at said back end to E plus 0.5-10 mmtowards said front end.

In an alternative embodiment,

We have shown the stem on the bite plate, but the bite plate may containthe socket, and the extraoral component may have the stem. Further, wehave shown a cylindrical shaft with jump ring circumnavigating the shaft(a cylindrical type snap fit), as one example of a reversible couplingmechanism, but any reversible coupling mechanism could be employed,including a cantilevered beam snap fit, a spherical snap-fit,depressible push pins and sockets, a threadable screw fit, and the like.

FIG. 11 shows the core (1007) of the bite plate, typically made from aresin, metal or ceramic having a harder durometer than the outersurface, and providing sufficient rigidity to the stem (1008) so as toallow it to lockingly fit into the socket. Cylindrical shaft (1009) hasa groove (1113), into which jump ring (1010) fits. Also featured arelocking pins (1011) and orientation pins (not shown), which prevent thebite plate from being inserted upside down. Generally plastics of atleast 40 Shore D are used for the core, but metals or ceramics couldalso be used. A coating is provided over this core, and provides thefinal shape of the bite plate, as shown in FIG. 10. Such coating shouldbe a biocompatible soft polymer of 40-70 Shore A, and particularlypreferred is a medical grade, clear silicone.

FIG. 12 shows a top plan view of the bite plate, more clearlyillustrating the core (1007), shaft (1009), flare (1112), pins (1011)and jump ring (1010), as well as the other edge of the overcoat, whichprovides the actual shape of the bite plate.

FIG. 13A-B shows the entire device including the bite plate (1000) andextraoral component (2000). The extraoral component comprises a housing(2001), which is ergonomically and aesthetically shaped, and has anon/off switch (2005), such as a membrane button and LED indicator light(2006). Preferably, both the LED and the on/off switch are containedwithin the same membrane, as this simplifies manufacturing and improvesreliability.

Inside the housing is the battery, processor and vibrator, as describedherein and not detailed in FIG. 13A-B. Also shown is an access hatch orcap (2002), that is connected to the body of the housing by tether(2004). This prevents the cap from being lost. By “tether” herein, anyform of attachment is meant, including a hinge, or coiled line. Insidethe hatch, USB connector (2003) is seen, which functions to bothtransmit data and to allow charging of a rechargeable battery, which ispositioned inside the housing and not accessible to the patient.

In preferred embodiments, the access hatch can only be opened with atool, e.g., via a small recess and cantilevered snap fit catch. This ispreferred because it reduces the regulatory burden, avoiding certain IEC60601 requirements. Also preferred, the battery is not accessible to thepatient, necessitating return to the manufacturer when/if the batteryneeds replacing. This configuration is desirable as further reducing theregulatory burden, reducing the risk of electrostatic discharge (EDS),and also allowing the manufacturer to reset the system and provide anyneeded refurbishment when/if the battery is changed. Further, thebattery is expected to last throughout the treatment period, andreplacements should rarely be required.

The processor collects raw usage data, including date and length of use.A certain amount of java code is contained in the chip, turning the USBinto a virtual flash drive, but any suitable code can be used. Thus,when the device is plugged into a computer, the code converts the rawdata into suitable graphics, as shown in FIG. 14A-B. Shown is date onthe x axis, and usage (% compliance, minutes of use, and numbers ofuses, all on the same scale) on the y axis. The x axis is equipped withscroll bars, which allow the practitioner to review the data moreclosely if desired (e.g. expand the time scale).

Daily usage is shown (largest scale data), along with 30 day averagedaily use (top line, excluding daily use), minutes of use (middle line),and number of uses (bottom-most line). Below the graph, lifetime usagedata is summarized. In this instance, the patient used the device onceor twice a day, skipping some days, and had an overall compliance of94%.

When the mouse passes over the data, a given day under the mouse isselected (see dots in FIG. 14B) and the data for that day is displayedon the upper right.

These graphics are not available on the device, which lacks a flashdrive and thus cannot be misappropriated or overwritten by patients.Instead, the small amount of code embedded in the processor converts theraw data to a usable form when plugged in and activated. This allows thesmallest footprint, reduces regulatory burdens, and still providesconvenient data analysis in a variety of forms, which can be used bypractitioners and in clinical trials. JavaScript code from an opensource package was used in our prototypes, called “dygraphs JavaScriptVisualization Library” (see code.google.com/p/dygraphs/), but any othercode could be used as well.

Setting the time and data on the prototype device requires an externalsource of communicating to the device. With the device connected to apersonal computer the user will navigate to the compliance data reportwhich will display instructions for the user to initiate a file saveoperation using their browser, which will access the product FLASH driveand enters a file name to save such as “DateTime”. The browser will savethe compliance report on the product FLASH drive under a given filename. The product will use the file creation date provided by theoperating system in the file save operation to set the real time clockin the device.

The cyclic force or vibration applied to the bite plate, toothpositioner, or other intraoral functional appliance is at frequenciesbetween 1 to 1000 Hz (preferably 10-100 Hz and most preferred 20-40 Hz)and a force of 0.01-2 Newtons (or 0.1-0.5 or 0.2 Newtons) for a periodof 1-60 minutes, preferably about 1-30 or 1-10 minutes or 20 minutes.This is followed by a period of recovery, ranging from 2-24 hours,preferably from 4-12 hours, and the cycle is repeated until one or moreteeth are successfully moved.

More particularly, the orthodontic appliance of the invention has avibrational source capable of providing a vibratory force at a frequencyof between 20 to 40 Hz or 30 Hz and a force of 0.1-0.5 Newtons or 0.25Newtons. Excess force is generally unpleasant to the patient, especiallyforce coupled with high frequency.

This is demonstrated in the graph at FIG. 16, which illustrates howhigher frequencies and forces change patient perception of the device.The graph shows that for patient comfort, a 30 Hz frequency should becoupled with a force of less than 1 Newton, although higher forces canbe comfortably used at lower frequencies. Fortunately, research has alsoconfirmed that very low magnitude force will suffice to significantlyimpact the rate of orthodontic remodeling.

While at least one study has shown increased hip density at 1 Hz(walking speed), suggesting that lower frequencies may have efficacy,further work will be required to elucidate the optimal frequencies fororthodontic applications. Furthermore, results applicable to long boneskeletal structure may well differ from optimal frequencies fororthodontic applications due to the differing biology of the dentalstructures.

In preferred embodiments these parameters are patient adjustable withinclinically efficacious ranges. In addition to capturing and storingusage data, the processor can also control the force and frequencyparameters, and appropriate controls or user interface can be providedfor same.

Preferably, the vibrating component has a more stable vibrator withimproved performance characteristics of decreased sound and low variancefrequency and force. In particular, the improved vibrator has a noiselevel less than 55 dB when measured at 6 inches, a frequency at 20-40Hz, with a variance of only 2 Hz, and a force of 0.1-0.5 Newtons, with avariance of +−0.05 N, or similar.

Consistency of frequency and force is achieved herein via a feedbackloop whereby motor speed is monitored and software adjusts the motor asneeded. More particularly, the motor contains an integrated encoder thatprovides multiple high and low signal outputs per motor revolution. Thesoftware counts the time between every encoder event (e.g., a rotatingdisc with markings thereon can be optically sensed) and compares this tothe desired target (e.g., 30 Hz). Based on this comparison, the softwarethen adjusts the pulse width modulation that is driving the motor toincrease or decrease speed as appropriate to maintain the desired speed.Accurate controlling of speed also controls the force.

Integrated optical encoders may be preferred, as one type of rotaryencoder, but the feedback mechanism can be any known technology.Encoders can be separate or integrated, and be optical, magnetic, orcapacitive encoders. A proportional-integral-derivative controller (PIDcontroller) is another option. The PID is a generic control loopfeedback mechanism widely used in industrial control systems.

A DC 6V Motor having off-set weight and 8 line integrated encoder isknown to provide these characteristics, but many other vibrators canalso provide these performance characteristics, and can be easily testedfor same. MicroMo Inc., for example has 8 and 16 line encodersintegrated with micromotors available at a variety of voltages, and manyother suppliers make similar devices. Preferably the battery is achargeable 100 mAh Li battery.

Custom devices can also be build, but off the shelf components are lessexpensive. Therefore, preferably, the motor is the Series 1506 DC Motor,by Micromo Electronics, Inc. (Part No. 1506N006SRIE2-8). Preferably thebattery is a 100 mAh Li—PO battery by Harding Energy (Part no.BAN-E601421).

Exemplary circuit diagrams are provided in FIGS. 15A-C. One embodimentthereof is described below.

Processor: The circuit utilizes a 32-bit low power processor to controlthe vibration motor, USB interface and user interface. The processorinterfaces to a EEPROM memory for storage and retrieval of usage data.The processor also interfaces to a digital, triaxial acceleration sensorthat is not used currently but may be used in future versions formonitoring device orientation and vibration characteristics for bothusage data and safety monitoring.

Power: The power circuit utilizes a battery charge management controllerto charge the battery and monitor the battery charge status. Batteryvoltage is regulated to 3.3 V.

Motor Control: Motor speed is regulated using a low-side transistorswitch controlled by the processor via pulse width modulation(Pulse-width modulation or PWM is a modulation technique that controlsthe width of the pulse, formally the pulse duration, based on modulatorsignal information, wherein the average value of voltage (and current)fed to the load is controlled by turning the switch between supply andload on and off at a fast pace such that the longer the switch is oncompared to the off periods, the higher the power supplied to the load).Motor speed is sensed by the processor by monitoring the digital signalfrom a reflective optical interrupter that detects transitions on anotched wheel attached to the motor shaft, and then speed adjusted usingPWM. To mitigate hazards caused by excessive motor speed, a dedicatedvoltage regulator limits the motor drive voltage to 1.2 V, thus limitingthe maximum motor speed to a safe level. In addition, the processor candisable the voltage regulator if a fault is detected.

User Interface: The user interface circuit drives LED current viatransistors that are controlled by the processor. Button press status ismonitored by the processor.

A cone beam device (GALILEOS™, by SIRONA™) was utilized to accuratelymeasure both roots and to estimate any resulting root resorption, withimaging in all three planes (sagittal, axial and coronal views). Thestudy was designed to determine if any root resorption greater than 0.5mm occurred or if there were alterations in root lengths, and nosignificant losses were found.

The study also measured distances between teeth using a digital caliper.The overall distance in millimeters between the front five teeth, bothupper and lower, was calculated during the alignment phase. The gapbetween teeth due to extractions was measured directly. The overallmovement rate during the study was 0.526 mm per week, which is higherthan average movement without the device.

We conclude that the device safely increases the rate of orthodontictooth movement and can be used with either fixed orthodontic appliancesor clear aligners, offering flexibility. This is useful given the mix oforthodontic therapies available and particularly since some patientshave combination therapy utilizing both fixed orthodontic appliances andclear aligner therapy. Short-term daily use for 20 minutes provides anadvantage for patients.

A phase 3 randomized clinical trial was performed with 45 patients,again with 25 grams and 30 Hz. The primary efficacy endpoint for thestudy was the difference in the weekly rate of tooth movement betweenthe device group and sham-control group.

The results demonstrate that the device described herein can increasethe rate of tooth movement when used in conjunction with conventionalorthodontics. The results confirm an accelerated tooth movement bothduring initial alignment (2.06 times or 106% faster) and space closure(1.38 times or 38% faster) phases of orthodontic treatment. Overalltreatment time was 50% faster.

Use of the device did not increase the risk of either root resorption orTAD loosening. The only potentially device-related events that occurredin more than one case in this clinical trial related to toothdiscomfort, soreness, or numbness, all of which are commonly reportedwith standard orthodontic treatment. In all cases, the events were mildand transient and none required discontinuation or any significantmodification of treatment procedures. Overall satisfaction, as well aseight specific assessments, indicates that patients accepted thetreatment well and easily incorporated the use of the device into theirdaily activities.

The direct clinical benefit from daily use of the device is shortenedtreatment time. In a case with an extraction space of 6-8 mm, the devicewill save the patient approximately 11-15 weeks during the space closurephase of orthodontic treatment. However, considering the acceleration oftooth movement during the alignment phase, the reduction to overalltreatment time is likely to be even greater. Further improvements inoverall compliance will probably also increase the overall accelerationobserved.

While the invention is described above in detail, it should beunderstood that various changes, substitutions, and alterations can bemade without departing from the spirit and scope of the invention asdefined by the following claims. Those skilled in the art may be able tostudy the preferred embodiments and identify other ways to practice theinvention that are not exactly as described herein. It is the intent ofthe inventors that variations and equivalents of the invention arewithin the scope of the claims while the description, abstract anddrawings are not to be used to limit the scope of the invention. Theinvention is specifically intended to be as broad as the claims belowand their equivalents.

Each of the following is incorporated by reference in its entirety forall purposes.

60/906,807 filed Mar. 14, 2007, US20080227046, US20080227047,US20100055634, US20120322018, US2013059263, US2013323669, US2011136070,Ser. No. 14/468,100 filed Aug. 25, 2014, and 61/901,154, filed Nov. 7,2013.

Kau, C. H. “A novel device in orthodontics.” Aesthetic Dentistry Today3:6 (2009): 42-43.

Kau, C. H. “A radiographic analysis of tooth morphology following theuse of a novel cyclical force device in orthodontics.” Head & FaceMedicine 7:14 (2011).

Kau, C. H., How et al., The clinical evaluation of a novel cyclicalforce generating device [AcceleDent®] in orthodontics, OrthodonticPractice 1(1): 10-15 (2010).

Kopher R A and Mao J J. Suture growth modulated by the oscillatorycomponent of micromechanical strain. 2003. J. Bone and Min Res. 18 (3).pp. 521-528.

Krishtab et al., [Use of vibratory action on the teeth to accelerateorthodontic treatment] [Article in Russian] Stomatologiia (Mosk). 1986May-June; 65(3):61-3.

Nishimura et. al. Periodontal tissue activation by vibration:Intermittent stimulation by resonance vibration accelerates experimentaltooth movement in rats. 2008. Am J Orthod Dentofacial Orthop 133(4) pp.572-583.

Peptan A I, et. al. Responses of intramembranous bone and sutures uponin-vivo cyclic tensile and compressive loading. 2008. Bone (42) pp.432-438.

Vij K. and Mao, J J. Geometry and cell density of rat craniofacialsutures during early postnatal development and upon in-vivo cyclicloading. 2006. Bone (38) pp. 722-730.

Werner, Alison. “Acceleration by Vibration.” Orthodontic Products(2011): 31, 35.

1. A method of maintaining a constant safe and effective vibration, said method comprising: a) providing a vibrating motor with an encoder operably connected to a processor having software that counts a time between a first encoder event and a second encoder event; b) comparing said time to a target frequency; c) adjusting a motor speed via pulse width modulation to increase or decrease said motor speed as appropriate to maintain said target frequency; such that a vibrating orthodontic remodeling device comprising an intraoral bite plate and an extraoral vibration source employing said method vibrates at a frequency between 20-40 Hz with a variance of ≦2 Hz, and a force between 0.1-0.5 N with a variance of ≦0.05 N when said bite plate is bitten by a patient and said device is activated.
 2. The method of claim 1, wherein said processor records usage data in said memory and on demand transmits said usage data via said data port to a patient or provider.
 3. The method of claim 2, wherein said processor collects usage data, including date and length of use, and stores said usage data in said memory and wherein embedded code is contained in said processor so as to convert the usage data into a graphic representation including daily use and average daily use when such usage data is downloaded to a computer via said data port.
 4. The method of claim 1, further comprising limiting battery voltage to 3.3 V using a battery charge management controller operatively coupled to said battery and said processor.
 5. The method of claim 1, further comprising limiting the vibration motor's drive voltage to 1.2 V with a dedicated voltage regulator.
 6. The method of claim 1, wherein adjusting motor speed uses a low-side transistor switch controlled by said processor.
 7. The method of claim 1, wherein said encoder is an integrated optical encoder.
 8. The method of claim 1, wherein said processor is a 32-bit low power processor.
 9. The method of claim 1, wherein said processor interfaces to a memory for storage and retrieval of usage data and is operably coupled to a data port.
 10. The method of claim 1, wherein said vibration motor is a 6V DC motor having an off-set weight and an 8 line integrated optical encoder.
 11. The method of claim 3, wherein said vibration motor is a 6V DC motor having an off-set weight and an 8 line integrated optical encoder.
 12. The method of claim 3, further comprising limiting battery voltage to 3.3 V using a battery charge management controller operatively coupled to said battery and said processor, and limiting the vibration motor's drive voltage to 1.2 V with a dedicated voltage regulator, and wherein adjusting motor speed uses a low-side transistor switch controlled by said processor.
 13. A method of maintaining a constant safe and effective orthodontic force and frequency, said method comprising: a) providing a processor to control an offset weight vibration motor and a battery to power said processor and said motor; b) said processor interfacing with an acceleration sensor or an encoder on said motor; c) measuring a speed of said motor with said acceleration sensor or said encoder; and d) regulating said speed of said motor by pulse width modulation and by a dedicated voltage regulator that limits a drive voltage of said motor; such that an orthodontic remodeling device comprising an intraoral bite plate and an extraoral vibration source employing the method of steps a-d vibrates at a frequency between 20-40 Hz with a variance of ≦2 Hz, and a force between 0.1-0.5 N with a variance of ≦0.05 N when said bite plate is bitten by a patient and said device is activated.
 14. The method of claim 13, wherein said processor interfaces to a memory for storage and retrieval of usage data and is operably coupled to a data port.
 15. The method of claim 14, wherein said processor records usage data in said memory and transmits said usage data on demand via said data port to a patient or provider.
 16. The method of claim 14, wherein said processor collects usage data, including date and length of use, and stores said usage data in said memory and wherein embedded code is contained in said processor so as to convert the usage data into a graphic representation including daily use and average daily use when such usage data is downloaded to a computer via said data port.
 17. The method of claim 13, wherein regulating said speed uses a low-side transistor switch controlled by said processor via pulse width modulation.
 18. The method of claim 13, wherein said voltage regulator limits the motor drive voltage to 1.2 V.
 19. The method of claim 13, further comprising limiting battery voltage using a battery charge management controller operatively coupled to said battery and said processor.
 20. The method of claim 13, wherein said processor is a 32-bit low power processor.
 21. The method of claim 13, wherein said encoder is an integrated optical encoder. 